Observation Study of Persons with Chronic Hepatitis B Virus infection in North America

Information

  • Research Project
  • 9539570
  • ApplicationId
    9539570
  • Core Project Number
    U01DK082874
  • Full Project Number
    5U01DK082874-10
  • Serial Number
    082874
  • FOA Number
    RFA-DK-16-512
  • Sub Project Id
  • Project Start Date
    9/30/2008 - 15 years ago
  • Project End Date
    5/31/2020 - 4 years ago
  • Program Officer Name
    DOO, EDWARD
  • Budget Start Date
    6/1/2018 - 6 years ago
  • Budget End Date
    5/31/2019 - 5 years ago
  • Fiscal Year
    2018
  • Support Year
    10
  • Suffix
  • Award Notice Date
    7/16/2018 - 5 years ago

Observation Study of Persons with Chronic Hepatitis B Virus infection in North America

Project Summary BACKGROUND The Hepatitis B Research Network (HBRN) was created in 2008 to address several research challenges regarding chronic hepatitis B (CHB). The HBRN was charged with establishing a large cohort of patients with hepatitis B virus (HBV) infection to study the natural history of HBV infection and designing treatment protocols(s) to compare monotherapy to combination therapy using clinical outcomes as endpoints. There are 12 consortia (22 clinical sites) recruiting adult and pediatric patients including the Toronto site (University Health Network, Toronto General Hospital & Hospital for Sick Children) to address the following specific aims: Specific Aims: 1. To describe participants with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression 2. To define the role of limited duration peginterferon alfa-2a in the presence of tenofovir for treating people with chronic hepatitis B (Immune Active (IA) Trial) 3. To evaluate ?off treatment? safety and sustained responses after treatment with entecavir and peginterferon alfa-2a in the treatment of chronic hepatitis B in HBeAg positive adults who are in the immune tolerant phase. (Immune Tolerant (IT) Trial) 4. The clinical and virological status of chronic HBV infection is defined by distinct patterns of immune effector and regulatory responses. 5. To examine if therapeutic HBV suppression will enhance antiviral immune effector responses and reduce immune inhibitory factors in participants with chronic hepatitis B With the highest number of enrolled patients and among the best retention rates in all categories of HBRN studies, Toronto is the leading site among the HBRN consortium. As of October 31st 2016, Toronto clinics have enrolled 437 patients including 300 adult and 137 pediatrics patients in the cohort study from a total number of 2427 (18%) enrolled patients across the network. Toronto also is the leading enrolling site in the two main treatment trials of the HBRN, the Adult Immune Active (IA) study and the pediatric/adult Immune Tolerant (IT) study. Toronto investigators are actively involved in numerous ancillary studies, including the ongoing immunology studies as well as studies on virological and clinical outcomes. Toronto investigators also participate actively on numerous committees throughout the network. Overall, in addition to retaining and recruiting patients, Toronto site has played an important role in the HBRN and will continue to be actively involved in all aspects of the network to ensure its continued success.

IC Name
NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
  • Activity
    U01
  • Administering IC
    DK
  • Application Type
    5
  • Direct Cost Amount
    866191
  • Indirect Cost Amount
    69295
  • Total Cost
    577003
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    847
  • Ed Inst. Type
  • Funding ICs
    NIDDK:577003\
  • Funding Mechanism
    Non-SBIR/STTR RPGs
  • Study Section
    ZDK1
  • Study Section Name
    Special Emphasis Panel
  • Organization Name
    UNIVERSITY HEALTH NETWORK
  • Organization Department
  • Organization DUNS
    208469486
  • Organization City
    TORONTO
  • Organization State
    ON
  • Organization Country
    CANADA
  • Organization Zip Code
    M5G 2M9
  • Organization District
    CANADA